Reliable sterility test kit Gamma Ray Sterilization AS cup 0.45μm
membrance
Our verification program requires technicians to continuously test
membrane filtration and direct immersion of 40 simulated samples
under unfavorable environmental conditions without false positive
results. Isolation technology is used to create conditions for a
sterile environment for testing drugs. The qualification conditions
for the isolator are extensive and the isolator is typically
sterilized using a chemical sterilizer.
The robustness of the sterilization process involves many problems.
Eligibility and maintenance of isolation and identification of
sterile systems may require a significant amount of work. Isolators
may not be the best cost method for solving environmental problems
when testing drugs in closed systems such as winteamTM. Standard
aseptic processing GMP can avoid most environmental problems. 5
Characteristics of Sterility Test Canister
- Conforms to the requirements of radiation sterilization of CP2010.
- Double-layer sterile packaging.
- Sterility testing: 14 days incubation, conforms to EP/USP
- Filter: bubble point method, bacterial retention test.
- Chewing stability test: The culture period is 14 days.
- l Ultrasonic welding process, the welding is smooth and sturdy, to
achieve the best sealing performance.
- Material of Filter Cartridge or Base: AS
- Material of Filter/ Clamping Piece/ Needle Base: ABS
- Material of Needle Case / Canister Base Stopper: PP
- Canister Cap: silica gel
100% passed the airtight performance testing;Passed the bacterial
challenge experiment and sterility test, which ensures reliable of
the sterility test.The united use of them keeps all process
carrying out in complete closed condition, including transfer,
filter and incubate, which avoids exogenous contamination.Product
sterility performance has been maintained and able to dialyze the
ethylene oxide quickly, its residues and packaging waste are
reduced, which fully reflects the corporate philosophy of
environmental protection;
parameter
| Schematic Diagram | Model | Inspection Style | Packing Spe. |
 | Py220C | Glass Bottle Large Volume Injection | 72Sets/Box 18sets/Box
48 Sets/Box 12sets/Box |
| Py330C |
| Ksf220C | Glass Bottle Large-Capacity Antibiotic Injection |
| Ksf330C |
 | Apy220C | Ampoule Injection |
| Apy330C |
| Kapy220C | Ampoule Antibiotic Injection |
| Kapy330C |
 | Dgb220C | Vial Bottle Soluble Powder |
| Dgb330C |
| Kdgb220C |
Vial Bottle Soluble Antibiotic Powder |
| Kdgb330C |
 | Sdy220C | Soft Bag Large Volume Injection |
| Sdy330C |
 | Fsy220C | Insoluble Liquid |
| Fsy330C |
 | Nkf220C | Powder That Needs To Be Dissolved And Diluted |
| Nkf330C |
The USP <71> sterility test consists of two qualifying tests
that must be performed prior to sterility testing, "adaptive
testing" (promoting growth testing) and "validation testing"
(antibacterial and fungal disease testing).
The suitability test is used to confirm that each growth medium
used in the sterility test procedure will support the growth of
less than 100 viable microorganisms, which will fail if the medium
does not support the growth of the indicator organism. According to
the culture parameters (time, temperature) determined by the
method, a part of each medium batch must be specially sterilized,
and if the medium is not sterilized, the test fails.
The verification test is used to determine whether the test sample
inhibits the growth of microorganisms in the test medium.
Microbiological retention means that the microorganism cannot grow
and proliferate in the microbial medium, and the bacteriostatic
medium does not necessarily kill the bacteria; it may It only
hinders the growth and reproduction of bacteria. Each product must
be tested for validation prior to and/or during the sterility test
to determine if the media volume is valid for a particular product.
Certain medical products contain bacteriostatic and fungistatic
compounds and may require special procedures and special media for
testing. This test is similar to the suitability test described
above, but the product sample is placed in the medium along with
the microorganisms. It was compared to a control without a test
sample. If microbial growth is present in the sample and control
containers, the next step is to perform an actual sterility test
that allows for simultaneous suitability, validation, and sterility
testing.
